Chemical Management

FAQ(Frequently Asked Questions: GHS classification results by the Japanese Government)

Japanese ⇔ English

We summarised the frequent questions on GHS classification results.
When you click the following button, the answers will appear.

1.The purpose of GHS classification projects by the Japanese Government

Q1-1What is the purpose of showing the GHS classification results by the Japanese Government?
A1-1

In Japan, in the GHS classification projects by the Japanese Government, the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) are conducting GHS classification from the Fiscal Year 2006 mainly for the substances under the control of the following acts which require making of SDS or labels etc.;

- Industrial Safety and Health Act (ISHA)

- Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR law)

- Poisonous and Deleterious Substances Control Act (PDSCA)


The classification results are shown in “GHS Classification Results (Excel, HTML)” on the NITE’s website. The information displayed includes 1) Classification for each hazard class, 2) Pictogram, 3) Signal word, 4) Hazard statement, and 5) The rationale for the classification for each substance. The results of approximately 3,000 substances are shown at present.

Classification results are shown to be used as a reference when business operators make an SDS and labels. It is not required in Japan to describe the same contents of the SDS and label assigned by the Japanese Government as they are.


Q1-2How are the target substances for GHS classification chosen?
A1-2

In the GHS classification projects by the Japanese Government, the target substances are chosen mainly among the substances under the control of the concerned laws/regulations, considering the amount of manufacture and import, the degree of public attention, and other factors.

Classification is also conducted for the substances for which notification and labeling (SDS and labels) are not mandatory required by Industrial Safety and Health Act (ISHA). However, not all hazardous substances in distribution are included. It is recommended to classify all the substances and mixtures that are thought to be hazardous and to share information by labeling and SDS.


Q1-3How are the target substances for GHS re-classification chosen?
A1-3

In the GHS classification projects by the Japanese government, re-classification may be conducted for some of the substances has already been classified. The target substances for re-classification are chosen in case of, for example, collection of new information, or revision of the GHS classification guidance for the Japanese government.

Therefore, it is recommended to refer to the latest classification results if multiple GHS classification results are available for the same substance. Furthermore, re-classification may be conducted only for a part of hazard classes such as carcinogenicity in health hazards or flammable liquids in physical hazards etc. Thus, this regard should be taken care.


Q1-4When are the GHS classification results released in public?
A1-4

The GHS classification projects of each ministry (MHLW, METI, MOE) will be conducted every fiscal year. The results are combined by NITE and are shown on the NITE’s website, available around June to September every year, depending on the time of receipt from the ministries and progress of NITE’s work.

The English translation for “Rationale for classification” in the GHS classification results will become available later than its Japanese version because NITE’s Chemical Management Center starts translation after the release of the GHS classification results in Japanese.


Q1-5Why are the GHS classification results by the Japanese Government different from those by the overseas authorities?
A1-5

The GHS classification results are released by some countries other than Japan. Their published results may be different from Japanese ones depending on the information sources used and judgments by experts. Exporting substances, with GHS classification results released in Japan as they are, may violate the laws/regulations of importing country. Therefore, please check those countries laws/regulations.

For example, the EU CLP Regulation assigns harmonized classification (corresponds to the GHS) and labeling of hazardous substances. It is generally called to be legally binding mandatory classification because the harmonized classification needs to be used for the distribution of substances listed in Annex VI to the CLP Regulation within the EU.

Harmonized classifications in the CLP Regulation are available on the following websites.

Furthermore, as for substances without harmonized classification by the CLP Regulation, each manufacturer or importer is required to submit the GHS classification results of substances when placing on the markets within the EU. Such information is also available in the following.

Other than this, GHS classification results are released by the governments of New Zealand, China, Korea, and other countries. In exporting, it is recommended to check each country’s rules to know the obligation to use the country’s classification results.

The classification results by some member states of ASEAN are available in the following.


2.Classification methods in the GHS classification projects by the Japanese Government

Q2-1How is the GHS classification by the Japanese government conducted?
A2-1

In Japan, in the GHS classification projects by the Japanese government, the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) have cooperated and conducted GHS classification from the Fiscal Year 2006 mainly for the substances under the control of the following acts which require preparation of SDS and labels;

- Industrial Safety and Health Act (ISHA)

- Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR law)

- Poisonous and Deleterious Substances Control Act (PDSCA)


In the GHS classification projects by the Japanese government, substances are classified according to the “GHS classification guidance for the Japanese Government”, which describes information sources to be used and classification methods for efficient GHS classification, and keeping the consistency of the classification methods among the ministries and agencies.

The GHS classification guidance for the Japanese government will be revised in accordance with the revision of the Globally Harmonized System of Classification and Labelling of Chemicals, United Nations (UN GHS, the Purple Book) and the update of the JIS (Japanese Industrial Standards). Therefore, depending on which revision of the guidance used, it is possible to use different information sources and judgment criteria.

The version of the GHS classification guidance used for each substance is shown in “GHS Classification Results (Excel, HTML)” on the NITE’s website. The GHS classification guidance for the Japanese government (older version) is available in the following.

The “GHS classification manual” and the “Technical Guidance on GHS classification”, which had been used in 2006 and 2007, are collected in the National Diet Library. Please search in the National Diet Library Digital Collections (only in Japanese) .


Q2-2Explain the information sources used in the GHS classification projects by the Japanese government.
A2-2

The GHS classification guidance used in the GHS classification projects by the Japanese government designates the information sources to be used to keep the consistency of the GHS classification methods among the ministries and agencies.

It is mentioned in the UN GHS (the purple book) that all available data are to be used, but the GHS classification guidance for the Japanese government lists the following information as available data. In some cases, the guidance sets priorities of information sources, depending on specifying original data sources (the credibility of the information sources).


  • The assessment documents provided by international organizations, governments of major countries, etc., whose reliability has been recognized
  • Useful documents, database, etc., other than the above assessment documents
  • Databases for searching primary literatures, reference databases, etc.
  • Please check the GHS classification guidance for the Japanese Government for details.

    Furthermore, some information used in the GHS classification projects is occasionally revised or updated. Therefore, it is important to check the version of such information when using the GHS classification by the Japanese Government.

    Besides, it is not ruled out in Japan to utilize data other than that specified in the GHS classification guidance by the Japanese Government. It is possible to use data, etc. that the business operator owns at their responsibility.


    Q2-3Explain who conducts the “GHS classification by the Japanese government.”
    A2-3

    In the GHS classification projects by the Japanese government, mainly the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) are conducting GHS classification. Each ministry selects the contractor for GHS classification projects and the contractor appoints experts experienced in hazards (physical, health, and environmental hazards) to the committee on GHS classification. The classification is done under the committee’s instruction according to the “GHS classification guidance for the Japanese government.”

    Therefore, please contact the following if you have any questions about the released GHS classification results. The contact is different from substance to substance, therefore please check which ministry conducted the classification. That is shown on the web page or spreadsheet for each substance (Excel, HTML).


    <Contact information about the contents of GHS classification results>

    ・Ministry of Health, Labour and Welfare (MHLW)

    Target substances: substances under the control of the Industrial Safety and Health Act (ISHA), and others
    Target hazards: physical and health hazards
    Chemical Hazards Control Division, Industrial Safety and Health Department, Labour Standards Bureau, Ministry of Health, Labour and Welfare
    Phone: +81-3-5253-1111 (extension 5517, 5514, 5509)
    FAX: +81-3-3502-1598

    ・Ministry of the Environment (MOE)

    Target substances: all substances applicable to GHS classification
    Target hazards: environmental hazards
    Environmental Health and Safety Division, Environmental Health Department, Minister's Secretariat, Ministry of the Environment
    Phone: +81-3-5521-8260
    FAX: +81-3-3580-3596

    ・Ministry of Economy, Trade and Industry (METI)

    Target substances: substances under the control of the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR law), and others
    Target hazards: physical and health hazards
    Chemical Risk Assessment Office, Chemical Management Policy Division, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry
    Phone: +81-3-3501-0080
    FAX: +81-3-3580-6347

    <Contact information about the released information on the website>

    Chemical Information Infrastructure Division, Chemical Management Center
    National Institute of Technology and Evaluation (NITE)
    Phone: +81-3-3481-1999
    Mail:Contact form

    Q2-4In Japan, as documents available for GHS classification, there are the UN GHS (the Purple Book), JIS Z 7252, GHS classification guidance for the Japanese Government, GHS classification guidance for enterprises, and others. Explain the contents of each document.
    A2-4

    The Globally Harmonized System of Classification and Labelling of Chemicals, United Nations (UN GHS, the Purple Book):

    The Globally Harmonized System of Classification and Labelling of Chemicals, United Nations (hereafter called UN GHS) was published in 2003, and it defines globally harmonized criteria for classification and labeling of chemicals (substances and mixtures) according to their hazards. Its contents are discussed in the United Nations, and it is revised every two years. The latest version is the eighth revised edition as of October 2019. As for the classification of chemicals, it defines hazards to be physical, health, and environmental hazards, and it sets judgment criteria for each hazard. As for the labeling of chemicals, it includes items related to hazard communication for chemicals such as requirements of safety data sheets (SDS). Concerning some rules on UN GHS, each country is given discretion on whether to determine how the contents of UN GHS are applied to their domestic systems, and the building block approach is adopted for the hazard category.

    JIS Z 7252 (Japanese Industrial Standards: Classification of chemicals based on “Globally Harmonized System of Classification and Labelling of Chemicals (GHS)”) :

    The Japanese Industrial Standard (JIS) related to the GHS was issued based on UN GHS to clarify the criteria for GHS classification in Japan. The JIS selectively adopted part of the contents of UN GHS considering the circumstances of laws and rules, etc. in Japan (building block approach). For example, the JIS does not adopt Category 5 in acute toxicity and Category 3 in skin corrosive/irritation, both of which are described in UN GHS. In handling chemicals overseas, caution should be taken on the laws and rules of the country. The latest version of JIS Z 7252, revised in May 2019 is based on the sixth revised edition of UN GHS.

    *JIS Z 7253: Hazard communication of chemicals based on GHS -Labelling and Safety Data (SDS) was revised together with JIS Z 7252 in May 2019.

    If you need more information about JIS, please contact the following office;

    Japanese Standards Association (JSA)
    Phone: +81-3-4231-8550
    FAX: +81-3-4231-8650
    E-mail: po@jsa.or.jp

    The GHS classification guidance for the Japanese Government:

    The GHS classification guidance for the Japanese Government is the guidance to conduct the GHS classification of the target substances by the ministries and agencies concerned effective and consistent in the GHS classification projects by the Japanese Government. It describes more detailed classification methods and information sources of data, etc. to be collected according to JIS Z 7252 so that GHS classification by the ministries and agencies concerned are based on the same criteria.

    Besides, in the Fiscal Year 2006 and 2007, GHS classification was conducted using the “GHS Classification Manual,” which defines practical methods for data collection and evaluation criteria for data reliability, and the “Technical Guidance on GHS classification,” which defines detailed technical principles and judgment criteria on health hazards. From the Fiscal Year 2008, those documents were integrated and had been maintained as the "GHS classification guidance for the Japanese government."

    The GHS classification guidance for enterprises :

    The Ministry of Economy, Trade and Industry (METI) released the “GHS classification guidance for enterprises,” which is a guide for enterprises to perform GHS classification accurately and efficiently by using JIS Z 7252. The guidance is based on the GHS classification guidance for the Japanese government, and it is a practical guide including GHS classification procedures for mixtures. It should be noted that to achieve a more reliable classification, a detailed investigation is required (checking original scientific papers, collection of new findings, hearing the views of experts, etc.).


    3.The relationship between the “GHS classification results by the Japanese government” and Japanese laws, etc.

    Q3-1Explain the relationship between GHS and Industrial Safety and Health Act (ISHA), Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR law), and Poisonous and Deleterious Substances Control Act (PDSCA) in Japan.
    A3-1

    As for laws that mention GHS-aligned SDS and labelling in Japan, there are mainly three laws, and the contents of their regulations are different from each other. As for their relationship, please refer to the leaflet summarizing it made by the Ministry of Economy, Trade and Industry (METI) and Ministry of Health, Labour and Welfare (MHLW).

    The relationship between GHS and each act is summarized below.

    <Industrial Safety and Health Act (ISHA)>

            

    Main compliance obligations

  • Obligations to offer SDS
  • Labeling obligations
  •         

    Substances subject to the regulation

  • Chemical Substances Requiring Labeling and Delivery of Documents, etc.
  • The substances with hazard category other than those above (duty to make efforts for preparing label and offering SDS)
  • Contact information

    Chemical Hazards Control Division, Industrial Safety and Health Department, Labour Standards Bureau, Ministry of Health, Labour and Welfare
    Phone: +81-3-5253-1111 (extension 5517, 5514, 5509)
    FAX: +81-3-3502-1598


    <Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR law)>

            

    Main compliance obligations

  • Obligations to offer SDS
  • Duty to make efforts for preparing labelling
  •         

    Substances subject to the regulation

  • Class I Designated Chemical Substances
  • Class II Designated Chemical Substances
  • Contact information

    Chemical Risk Assessment Office, Chemical Management Policy Division, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry
    Phone: +81-3-3501-0080
    FAX: +81-3-3580-6347



    <Poisonous and Deleterious Substances Control Act (PDSCA)>

            

    Main compliance obligations

  • Obligations to show information such as a substance name, components, amounts, and a manufacturer or importer
  • Obligations to offer information on properties of substances and precautions for handling
  •         

    Substances subject to the regulation

  • Poisonous substances
  • Deleterious substances
  • Contact information

    Office of Chemical Safety, Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare
    Phone: +81-3-5253-1111 (the main number for the ministry)


    As described above, required items are different from act to act. In general, to achieve the requirements of the acts, it is required to make GHS-aligned SDS and labels according to JIS Z 7252 and 7253.

    Please contact each competent authority for detailed or updated information on the act.


    Q3-2Explain the relationship between GHS and the other laws in Japan.
    A3-2

    The laws that mention GHS and JIS Z 7252 and 7253 are mainly three acts: Industrial Safety and Health Act (ISHA), Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR law), and Poisonous and Deleterious Substances Control Act (PDSCA). Some laws other than these also require notifications and labelling of chemical hazard information. Laws which specify labelling include Fire Service Act, Agricultural Chemicals Regulation Act, High Pressure Gas Safety Act, and Explosives Control Act, etc.

    Furthermore, it is described in “Item 15 - applicable laws for SDS” in JIS Z 7253 that it is preferable to include the name and regulation information of the applicable law other than the three acts mentioned above in SDS. As for sample labels and SDS, please refer to the following website.

    Besides, it is possible to search for applicable laws including the three acts on NITE-CHRIP.

    Q3-3Explain the relationship with sample label and SDS by the Ministry of Health, Labour and Welfare (MHLW).
    A3-3

    In the Workplace Safety Site of the Ministry of Health, Labour and Welfare (MHLW), GHS aligned sample labels and SDS are shown as a reference for making SDS and labels. The sample labels and SDS were made using the “GHS classification results by the Japanese Government” for hazard classes.

    However, it is probable that hazard information in the sample labels and SDS is different from the latest GHS classification results by the Japanese government, depending on the progress of the release. For the latest information, please check the “GHS classification results by the Japanese government” released at the NITE’s website.


    4.The contents of the “GHS classification results by the Japanese government”

    Q4-1Explain the meaning of giving a hazard category in the GHS classification results.
    A4-1

    The GHS classification results conducted by the ministries are shown in the “GHS classification results by the Japanese government.” Their contents are described in the column of “Classification” in the spreadsheet or webpage (HTML) of each substance.

    In “Classification,” the classification result on hazards based on GHS is shown. Therefore, when the hazard category is given based on GHS, it means that the substance has a physical, health, or environmental hazard. In that case, caution should be taken on handling it.

    Specific meaning and hazard given for each hazard category are summarized in JIS Z 7252, 7253, and UN GHS. Please refer to them.

    If you need more information about JIS, please contact the following office;

    Japanese Standards Association (JSA)
    Phone: +81-3-4231-8550
    FAX: +81-3-4231-8650
    E-mail: po@jsa.or.jp

    Furthermore, it is recommended to check the Hazard statement (H code) and the Precautionary statement (P code) linked to each hazard category.

    Not giving a hazard category to a substance does not guarantee its safety. GHS classification is conducted based on the data available at the time of classification, therefore, there is the case where the category is not given due to no information. Precautions are needed on the fact that all substances possibly cause harm to human health or the environment by misuse.


    Q4-2Explain the meaning of no hazard category given (Not classified, Classification not possible, Not applicable)
    A4-2

    In the GHS classification results by the Japanese government, the GHS classification results are shown based on the physical, health, and environmental hazard. Following words are displayed when a hazard category is not given. Their meanings are summarized below.

    Words in Classification Meaning
    “Not classified” Where sufficient information for classifying a substance is available, sufficient evidence was found to determine that it is not applicable to any hazard category defined by GHS through classification (including the case where data are available to determine that it is applicable to Category 5 in acute toxicity in UN GHS classification that JIS does not adopt, but not Category 1-4). Or in the case where information was not judged to be clear evidence to give a category.
    “Classification not possible” In case no data are available for GHS classification after searching various information sources, or in case sufficient data for GHS classification are not available.
    “Not applicable” Substances not subject to classification because they do not have physical states or chemical structures written in the GHS definition.

    Not giving a hazard category to a substance does not guarantee its safety. GHS classification is conducted based on the data available at the time of classification, therefore, there is the case where the category is not given due to no information. Precautions are needed on the fact that all substances possibly cause harm to human health or the environment by misuse.

    Q4-3Explain the meaning of “-” displayed in the re-classification results.
    A4-3

    In the GHS classification projects by the Japanese government, re-classification may be conducted based on the latest data or the revised GHS classification guidance for the Japanese government for some of the substances already classified.

    Re-classification may be conducted only for part of hazard classes (such as carcinogenicity, flammable liquids, and environmental hazards). In that case, “-” is shown in the classification for the hazard classes not applicable to re-classification. For those hazard classes with “-,” please refer to the previous GHS classification results, which would be the latest for the hazard classes.


    Q4-4Explain the meaning of “*” displayed in the classification results.
    A4-4

    For the fiscal year 2019, an asterisk “*” may be used in the column of “Classification” in the GHS classification results conducted by the Ministries. An asterisk “*” denotes “Not classified (or No applicable)” and/or “Classification not possible.” In that case, please refer to the details described in the column of “Rationale for the classification.” If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.


    Q4-5Explain the contents described in the Rationale for classification.
    A4-5

    NITE is releasing “the GHS classification results by the Japanese Government” as a reference for making labels and SDS by business operators. Therefore, the reason for judgment on the GHS classification results and points of concern at the time of the classification are described in the “Rationale for classification” to show which information was used for the classification.

    For part of hazard classes, a hazard category is given based on quantitative data. However, for many other classes, semiquantitative or qualitative criteria are used, and there is a case where expert judgment is required to interpret the data. Such judgments, etc. are described in the “Rationale for classification.”


    Q4-6Explain about Hazard statement (H code) and Precautionary statement (P code).
    A4-6

    In the GHS classification results by the Japanese government, Hazard statement (H code) and Precautionary statement (P code) are shown based on the hazard category given.

    Hazard statement (H code)

    - It describes the nature of the hazards, including the degree of the hazards.

    Precautionary statement (P code)

    - It describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to a hazardous product, or improper storage or handling of a hazardous product

    In “H code” and “P code,” three-digit codes (such as P260 and H370) are given and shown based on the hazard category of a substance. As for H codes and P codes, the tables for H codes and P codes with hazard category in the JIS Z 7253 are being used.

    Besides, as for H codes and P codes, please refer to the updated information in UN GHS because the codes undergo revision, etc. based on UN GHS accordingly.

    If you need more information about JIS, please contact the following office;

    Japanese Standards Association (JSA)
    Phone: +81-3-4231-8550
    FAX: +81-3-4231-8650
    E-mail: po@jsa.or.jp

    <Reference>

    H codes and P codes are used to refer to the hazard statement and the precautionary statement in the GHS classification, and are not part of them. Therefore these codes should not be used to replace in place of the hazard statement and the precautionary statement.

    Labels and SDS are required to describe all factors. However, JIS Z 7253 states that for labels, "It is desirable that the description should be highly visible and that the SDS should be referenced for details," and that "the person responsible for labeling should select appropriate precautionary statement and describe the appropriate precautionary statement."


    5.Website contents of NITE’s own

    Q5-1Who translates “the GHS classification results by the Japanese government” into English?
    A5-1

    The “GHS classification results by the Japanese government” conducted mainly by the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) are combined by NITE and are shown on the NITE’s website. NITE is translating the classification results into English except for the Fiscal Year 2006.

    NITE is releasing the English version together with the Japanese version for basic information such as chemical names and hazard categories. While the English translation for “Rationale for classification” will become available later than its Japanese version because translation starts after the release of the GHS classification results in Japanese. Furthermore, the English translation is also continued to be conducted for “Rationale for classification” in the former GHS classification results by the Japanese government, but please note that not all translation is finished.

    Q5-2Explain how to use the “table for hazard categories for all target substances” in the “GHS classification results by the Japanese government”?
    A5-2

    It is possible to see the “GHS classification results by the Japanese government” on the web or in the Excel for each substance. To fulfill the request to see hazard categories for all substances at once, NITE is providing the “table for hazard categories for all target substances.”

    The following file is useful to extract the substances received a specific hazard category or to compare the classification result with the one in the past.

    Q5-3Explain about the schedule of the next revision of UN GHS.
    A5-3

    UN GHS (the Purple Book) undergoes a revision every two years, which is discussed by the United Nations Sub-Committee of Experts on GHS. The contents of the revision of UN GHS are proposed mainly by experts of each country and organization and determined after the approval of the experts. Because the contents of the revised UN GHS will be regularly reflected in the JIS, it is important to keep an eye on the contents of the revision, which will be applied in the future.

    Furthermore, NITE translated the reports released by the United Nations Sub-Committee of Experts on GHS into Japanese and posted them on the NITE’s website.

    The Sub-Committee for the eighth revised edition of UN GHS

    The Sub-Committee for the ninth revised edition of UN GHS

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    Last Update

    12.14.2020

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    Chemical Management Center, National Institute of Technology and Evaluation
    Phone number:+81-3-3481-1999
    Fax number:+81-3-3481-2900
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